3RODULW 7( ,QF – FDA EIR, Jul 13, 2018

A comprehensive FDA Good Manufacturing Practice (GMP) inspection of PolarityTE, Inc., a biological drug manufacturer located in Salt Lake City, UT, was conducted from July 9-13, 2018. The inspection, requested by the Center for Biologics Evaluation and Research, focused on the manufacturing of the firm's SkinTE™ autologous human tissue product, under regulations outlined in the Public Health Service and Federal Food, Drug, and Cosmetic Acts, specifically 21 CFR 210, 211, and 600. The inspection revealed eight significant observations documented on an FDA-483. Key deficiencies included the absence of written procedures for production and process controls to ensure product quality and purity, and buildings not suitably constructed to facilitate proper cleaning and maintenance. Aseptic processing areas lacked adequate environmental monitoring and cleaning/disinfecting systems, and defined areas to prevent contamination were deficient. Further issues involved the lack of a stability testing program, a quality control unit with insufficient authority for investigations, and unrecorded laboratory control mechanisms. Additionally, five discussion items were raised, highlighting no cleaning effectiveness validation, deficient batch record control, absence of smoke study videos for airflow, lack of incoming material certificate of analysis evaluation, and no documented GMP training for employees. PolarityTE, Inc. has committed to providing a written response to all observations within 15 business days.